INSULIN Act of 2026

(10) Expediting biosimilar competition

(A) In general. The Secretary may, at the request of the sponsor of an application under this subsection for licensure of a biosimilar biological product that is designated as a competitive biosimilar biological product pursuant to subparagraph (B), expedite the development and review of such application under this subsection.

(B) Designation process

(i) Request. The sponsor of an application under this subsection may request the Secretary to designate the drug as a competitive biosimilar biological product. A request for such designation may be made concurrently with, or during the 60-day period immediately prior to, the submission of a biosimilar biological product license application under this subsection.

(ii) Criteria. A biosimilar biological product is eligible for designation as a competitive biosimilar biological product under this paragraph if the Secretary determines that there is inadequate biosimilar competition.

(iii) Designation. Not later than 60 calendar days after the receipt of a request under clause (i), the Secretary may—

(I) determine whether the biosimilar biological product that is the subject of the request meets the criteria described in clause (ii); and

(II) if the Secretary finds that such product meets such criteria, designate the biosimilar biological product as a competitive biosimilar biological product.

(C) Inadequate biosimilar competition. In this paragraph, the term inadequate biosimilar competition means that, with respect to a biological product licensed under subsection (a)—

(i) on the list published under paragraph (9)(A) (not including biological products on the discontinued section of such list), there are fewer than 3 biological products licensed under this subsection pursuant to an application that uses such biological product licensed under subsection (a) as a reference product; and

(ii) not less than 3 years have passed since the expiration of all exclusivity periods applicable to such biological product licensed under subsection (a), or applicable to a biosimilar biological product licensed under this subsection using such biological product licensed under subsection (a) as a reference product, including any exclusivity periods under—

(I) paragraph (6);

(II) paragraph (7)(A);

(III) section 527 of the Federal Food, Drug, and Cosmetic Act; and

(IV) subsection (m).